Busse Hospital Disposables Convenience Kit Swab Recall for Test Validation Uncertainty
Busse Hospital Disposables is recalling convenience kits containing swab products due to uncertainty about adequate validation of manufacturing test methods.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall for manufacturing test validation uncertainty with no reported illnesses, injuries, or confirmed product defect. The recall is precautionary in nature, addressing process validation gaps rather than confirmed contamination.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling convenience kits containing swab and swabstick products manufactured by Professional Disposables International (PDI). The affected lot number is 2110052, with UDI 00849233005419. A total of 30 units were distributed nationwide.
The recall was initiated due to uncertainty regarding the adequacy of validation of the test methods used to manufacture the products. The company cannot confirm that the manufacturing test procedures were properly validated, raising questions about whether products meet required specifications and quality standards.
Customers who received affected products should discontinue use and contact Busse Hospital Disposables, Inc. for instructions on return or disposal. This Class II recall indicates a situation where product use may result in adverse health consequences.
The recalled product
- Product
- SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug — Medical supplies / Swabs
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 2110052 UDI: 00849233005419
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 58 recalled by Busse Hospital Disposables, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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